A Study of exoASO-STAT6 (CDK-004) in Patients With Advanced Hepatocellular Carcinoma (HCC) and Patients With Liver Metastases From EIther Primary Gastric Cancer or Colorectal Cancer (CRC)

1. Must have one of the following cancer types:

1. Advanced HCC defined as Barcelona Clinic Liver Cancer (BCLC) Stage B/C not amenable to resection or locoregional therapy;

2. Histologic or radiologic proof of liver metastasis from primary CRC which is unresectable with no evidence of extrahepatic metastasis;

3. Histologic or radiologic proof of liver metastasis from primary gastric cancer which is unresectable with no evidence of extrahepatic metastasis.

2. Documented progression after at least 1 line of FDA approved systemic therapy for advanced HCC/gastric cancer/CRC or intolerable/refuse to chemotherapy.

3. ≥ 18 years of age at screening.

4. Measurable disease by RECIST v1.1.

5. Able to provide archival tumor tissue/fresh biopsy prior to study treatment and on-treatment tumor biopsies if considered safe and medically feasible by the Investigator.

6. ECOG performance status of 0-2.

7. Acceptable liver function

8. Acceptable renal function

9. Acceptable hematologic status

10. Cirrhosis classified as Child-Pugh Class A (applicable only to patients diagnosed with cirrhosis)..

11. Women of child-bearing potential agree to use highly effective contraceptive methods and avoid egg donation and preservation during the study treatment and for 6 months after the last dose of study drug.

12. Men of child-producing potential agree to use highly effective contraceptive methods and avoid sperm donation and preservation during the study treatment and for 6 months after the last dose of study drug.

12. History of liver transplant.

13. History of immunodeficiency or is receiving chronic systemic steroid therapy

14. Poorly controlled diabetes mellitus.

15. Active or previously documented autoimmune or inflammatory diseases

16. Is currently participating in a study of an investigational therapy or device or has participated and received an investigation therapy or device within 3 weeks of administration of CDK-004.

17. Has another physical or mental health disorder that might cause difficulty in obtaining informed consent and/or participation in the trial

What this study is about